MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM

Model Number AB2000

Device Problems Mechanical Problem (1384); Dent in Material (2526); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that the patient presented with a very high bladder neck and during the procedure, the aquabeam handpiece hypotube bent upon insertion in the patient and in the upward direction in the urethra.New handpiece and scope units were opened and again the handpiece hypotube bent and the treating surgeon was not able to retract the scope.A third handpiece was able to be put in place and treatment was completed without any further issues.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam handpiece and associated aquabeam scope were returned for investigation of this event.It was confirmed that the scope was stuck in the handpiece along with the scope carriage and scope carriage could not be translated to move the scope.Pliers were used to try to remove the scope carriage from the handpiece, but the attempt was unsuccessful.Cracking was seen on the adhesive of the handpiece which is indicative of the handpiece experiencing higher forces than usual.A review of the device history record (dhr) ab2000-b/serial number (b)(6) and associated aquabeam handpiece/ lot number 22c00216 was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system user manual, um0101 rev.F, states the following: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup: using the knobs on the carriage, advance the aquabeam scope forwards (distal) and backwards (proximal) to ensure that the aquabeam scope is fully engaged with the aquabeam handpiece.The scope tube tip should move forwards and backwards in concert with the movement of the aquabeam scope a similar complaint review for a 12-month perioud was conducted, which confirmed one (1) similar event has been reported to procept.It is possible that the unusual patient anatomy caused the handpiece to bend slightly causing the scope inside to be stuck; however, cause cannot be confirmed.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 14570485
• MDR Text Key: 300338444
• Report Number: 3012977056-2022-00075
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190604X
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male